Cleared Special

K173480 - Crystalsert Lens Delivery System

K173480 is an FDA 510(k) clearance for Crystalsert Lens Delivery System, manufactured by Bausch & Lomb, Inc.. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Special 510(k) pathway after a 28-day FDA review.

K173480 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
28d
Days
Class 1
Risk

K173480 is an FDA 510(k) clearance for the Crystalsert Lens Delivery System. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Bausch & Lomb, Inc. (St. Louis, US). The FDA issued a Cleared decision on December 11, 2017 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K173480

510(k) Number K173480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2017
Decision Date December 11, 2017
Days to Decision 28 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 110d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

MSS Device Classification - Class 1, General Controls

Product Code MSS Folders And Injectors, Intraocular Lens (iol)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MSS Folders And Injectors, Intraocular Lens (iol)

All 62
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K173480.
BL-Cart IOL Delivery Cartridge
K182965 · Ast Products, Inc. · Mar 2019
RxSight Insertion Device
K181401 · Rxsight, Inc. · Jul 2018
pioli IOL Delivery System
K172228 · Ast Products, Inc. · Dec 2017
MicroSTAAR Injector System Cartridges
K172375 · STAAR Surgical Company · Sep 2017
Lenstec LC Injection system
K161776 · Lenstec, Inc. · Nov 2016
Easy-Load Lens Delivery System
K161012 · Bausch and Lomb, Inc., · Jul 2016
K173480 · Crystalsert Lens Delivery System
Download PDF FDA Summary Bausch & Lomb, Inc.